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Procedure
ACL Reconstruction Techniques for Anterior Cruciate Ligament Injury
N/A
Recruiting
Led By Stephanie Mayer, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients ages 12 to 19 (inclusive)
Patients undergoing primary ACL reconstruction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 to 2 years
Awards & highlights
Study Summary
This trial is comparing two methods of ACL reconstruction in kids to see which is better in the short, intermediate, and long term.
Who is the study for?
This trial is for boys and girls aged 12-19 who need their first ACL reconstruction due to injury or tear. It's not for those with neuromuscular issues, neurological injuries, recent severe leg trauma, or systemic/musculoskeletal conditions.Check my eligibility
What is being tested?
The study compares two surgical techniques for pediatric ACL reconstruction: one using a tendon-bone graft and the other an all-tendon graft. The goal is to see which method leads to better outcomes in the short, medium, and long term.See study design
What are the potential side effects?
While specific side effects are not listed here, typical risks of ACL surgery may include pain at the graft site, infection risk post-surgery, stiffness or loss of motion in the knee joint.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 12 and 19 years old.
Select...
I am having my first ACL surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Long-Term Graft Superiority
Short-Term Graft Superiority
Secondary outcome measures
Patient Reported Outcomes
Time to Return to Sports Rates
Trial Design
2Treatment groups
Active Control
Group I: Tendon-Bone GraftActive Control1 Intervention
Participants receive the Quadriceps Tendon Tendon-Bone Graft technique during ACL reconstruction.
Group II: All-Soft-Tissue GraftActive Control1 Intervention
Participants receive the Quadriceps Tendon All-Soft-Tissue Graft technique during ACL reconstruction.
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Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,736 Previous Clinical Trials
2,149,045 Total Patients Enrolled
1 Trials studying Anterior Cruciate Ligament Injury
178 Patients Enrolled for Anterior Cruciate Ligament Injury
Children's Hospital ColoradoOTHER
116 Previous Clinical Trials
5,132,465 Total Patients Enrolled
Stephanie Mayer, MDPrincipal InvestigatorChildren's Hospital Colorado
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am either male or female.I have a diagnosis related to my body's systems or bones and muscles.I had surgery for a leg injury within 2 years before my ACL injury.I am between 12 and 19 years old.You have a pre-existing neurological condition or injury affecting your muscles or nerves.I am having my first ACL surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Tendon-Bone Graft
- Group 2: All-Soft-Tissue Graft
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this medical study currently enlisting participants?
"It appears the clinicaltrials.gov database has this trial listed as being inactive. The initial posting was on August 31st 2019 and it was last updated July 29th of that same year. While no longer open to participants, there are still 174 trials available for enrollment at this time."
Answered by AI
Is the enrollment of individuals aged 85 and above included in this research?
"As specified by the study's inclusion criteria, only adolescents aged 12-19 may participate in this medical trial."
Answered by AI
Who might be a suitable candidate for this medical experiment?
"The trial seeks to recruit 150 minors aged 12-19 who have sustained an anterior cruciate ligament tear. In order for a patient to qualify, they must satisfy the age requirement (12-19 years old)."
Answered by AI
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